Selenium Supplementation for Improving Depression in Children and Adolescents: Efficacy and Mechanistic Study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 172
- 试验地点
- 1
- 主要终点
- Change in BDI-II (Baker Depression Scale) scores from baseline
研究概览
简要总结
The purpose of this study is to investigate the role and mechanisms of selenium in depression among children and adolescents, aiming to provide new insights for understanding the pathogenesis and treatment of depression in this population.
详细描述
This randomized, double-blind, placebo-controlled trial will evaluate the efficacy and safety of selenium supplementation (selenium yeast) combined with fluoxetine in children and adolescents with major depressive disorder (MDD). Eligible participants are aged 12-18 years, meet DSM-5 criteria for a current depressive episode, and have a CDRS-R score ≥40 confirmed by trained psychiatrists. A total of 172 participants will be randomized 1:1 to receive either fluoxetine plus selenium yeast or fluoxetine plus placebo. Selenium yeast will be administered at 60-200 μg/day. Fluoxetine will begin at 10 mg/day and may be adjusted by the treating psychiatrist within a range of 20-60 mg/day. The placebo consists of commercially available yeast tablets identical in appearance, taste, and size to selenium yeast, administered at 60-200 μg/day. Biological samples (blood, urine, stool) will be collected for routine laboratory tests, thyroid, liver, and kidney function, and serum will be analyzed for selenium and ferroptosis-related biomarkers. Brain MRI will also be performed. These assessments will be repeated at weeks 4 and 8 of treatment, together with rating scale evaluations and biospecimen collection. The primary outcome is the change in depressive symptoms, measured by the CDRS-R and Beck Depression Inventory-II (BDI-II). Secondary outcomes include anxiety symptoms (SCARED, HAMA), overall clinical improvement (CGI-S, CGI-I), manic symptoms (YMRS), suicide risk (C-SSRS), quality of life (PedsQL 4.0), sleep quality (PSQI), and rumination (RRS). Safety will be monitored through adverse events, vital signs, laboratory tests, and tolerability assessments. This study will provide preliminary evidence on the adjunctive role of selenium supplementation in fluoxetine treatment for adolescent depression and inform future large-scale trials.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 12-18 years;
- •Diagnosed with major depressive disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), using the K-SADS-PL diagnostic tool;
- •A score of ≥40 on the Children's Depression Rating Scale-Revised (CDRS-R);
- •Adequate visual and auditory abilities to complete the study;
- •Willingness to participate in the study with informed consent signed by both the participant and a legal guardian.
排除标准
- •Patients with severe psychiatric disorders such as bipolar disorder, schizophrenia, bulimia nervosa, anorexia nervosa, or primary obsessive-compulsive disorder;
- •Those with severe physical illnesses or other life-threatening conditions; patients in a current depressive episode with a clear suicidal plan or history of suicide attempt;
- •Individuals with a history of substance or drug abuse;
- •Those requiring immediate hospitalization for psychiatric disorders;
- •Patients currently taking medications contraindicated with the investigational drug or that may interfere with its efficacy;
- •Those who have received modified electroconvulsive therapy (MECT) within the past 12 months;
- •Individuals allergic to selenium yeast protein, including those with allergic rhinitis, gastrointestinal sensitivity, allergic constitution, or autoimmune diseases such as Graves' disease or Hashimoto's thyroiditis;
- •Patients with contraindications to magnetic resonance imaging (MRI);
- •Left-handed individuals.
研究组 & 干预措施
Fluoxetine combined with selenium yeast therapy
In this group, participants will receive standard fluoxetine treatment along with adjunctive selenium yeast supplementation at a daily dose of 60-200 μg, aiming to investigate the role and mechanisms of selenium yeast in fluoxetine therapy.
干预措施: selenium yeast supplementation (Drug)
Fluoxetine combined with placebo therapy
Participants in this group, in addition to receiving conventional fluoxetine treatment, were administered 60-200 µg per day of a placebo identical in appearance and odor to selenium yeast as adjunctive therapy. The aim was to investigate the role of selenium yeast in fluoxetine treatment and to clarify whether it enhances the therapeutic effect.
干预措施: Placebo yeast supplementation (Drug)
结局指标
主要结局
Change in BDI-II (Baker Depression Scale) scores from baseline
时间窗: Baseline, Week 4 and Week 8 of treatment
The BDI-II (Beck Depression Inventory-II) is a self-report scale for assessing depression, with a minimum score of 0 and a maximum score of 63. Higher scores indicate more severe depression. One of the secondary outcome measures is the change in the BDI-II score compared to the baseline.
Change in CDRS-R (Children's Depression Rating Scale) scores from baseline
时间窗: Baseline, Week 4 and Week 8 of treatment
The Children's Depression Rating Scale-Revised (CDRS-R) has a minimum score of 17 and a maximum score of 113. Higher scores indicate greater severity of depression. The primary outcome measures are the response and remission rates of depressive symptoms. Treatment response is defined as a ≥50% reduction in the CDRS-R total score from baseline, whereas remission is defined as a CDRS-R total score ≤28；
Change in BDI-II (Beck Depression Inventory-II) scores from baseline
时间窗: Baseline, Week 4 and Week 8 of treatment
The BDI-II (Beck Depression Inventory-II) is a self-report scale for assessing depression, with a minimum score of 0 and a maximum score of 63. Higher scores indicate more severe depression. One of the secondary outcome measures is the change in the BDI-II score compared to the baseline.
Change in CDRS-R (Children's Depression Rating Scale) scores from baseline
时间窗: Week 4 and Week 8 of treatment
The Children's Depression Rating Scale-Revised (CDRS-R) has a minimum score of 17 and a maximum score of 113. Higher scores indicate greater severity of depression. Primary Outcome Measure is clinical response (≥ 50% reduction in CDRS-R scores from baseline)；
次要结局
- Change in CGI-I (Clinical Global Impressions-Improvement Scales) scores from baseline(Week 4 and Week 8 of treatment)
- Change in SCARED (The Screen for Child Anxiety-Related Emotional Disorders) scores from baseline(Baseline, Week 4 and Week 8 of treatment)
- Change in Hamilton Anxiety Rating Scale (HAMA) scores from baseline(Baseline, Week 4 and Week 8 of treatment)
- Change in suicide risk from baseline on the C-SSRS (Columbia Suicide Severity Rating Scale)(Baseline, Week 4 and Week 8 of treatment)
- Change in PSQI (Pittsburgh Sleep Quality Index) scores from baseline(Baseline, Week 4 and Week 8 of treatment)
- Change in PedsQL4.0 (The Pediatric Quality of Life Inventory) scores from baseline(Baseline, Week 4 and Week 8 of treatment)
- Change in CGI-S (Clinical Global Impressions-Severity Scales) scores from baseline(Baseline, Week 4 and Week 8 of treatment)
- Change in RRS (Ruminative Responses Scale)(Baseline, Week 4 and Week 8 of treatment)
- Change in Young Mania Rating Scale (YMRS)(Week 4 and Week 8 of treatment)
- Change in PedsQL4.0 (The Pediatric Quality of Life Inventory 4.0) scores from baseline(Baseline, Week 4 and Week 8 of treatment)
- Change in suicide risk from baseline on the C-SSRS (Columbia Suicide Severity Rating Scale)(Week 4 and Week 8 of treatment)
- Change in BDI-II (Baker Depression Scale) scores from baseline(Week 4 and Week 8 of treatment)
- Change in SCARED (The Screen for Child Anxiety-Related Emotional Disorders) scores from baseline(Week 4 and Week 8 of treatment)
- Change in CGI-S (Clinical Global Impressions-Severity Scales) scores from baseline(Week 4 and Week 8 of treatment)
- Change in PSQI (Pittsburgh Sleep Quality Index) scores from baseline(Week 4 and Week 8 of treatment)
- Change in PedsQL4.0 (The Pediatric Quality of Life Inventory) scores from baseline(Week 4 and Week 8 of treatment)
- Change in CGI-I (Clinical Global Impressions-Improvement Scales) scores from baseline(Week 4 and Week 8 of treatment)
- Change in RSS (Ruminative Responses Scale)(Week 4 and Week 8 of treatment)
研究者
Xinyu Zhou
professor
First Affiliated Hospital of Chongqing Medical University